The drug Trasylol, used during open-heart surgery to reduce blood loss, has become the subject of a growing number of lawsuits. In these suits, it’s alleged that the drug, manufactured by Bayer, causes renal failure and other risks, including heart failure and stroke. As we have previously reported, the FDA suspended sales of Trasylol in November 2007 after it had been on the market for 14 years. The number of people affected could be most significant because the drug was used quite often during open-heart surgery.
Trasylol was used in surgery and not prescribed. Most patients wouldn’t know at the time of their surgery that it was being used. It’s estimated that 4.5 million patients worldwide have been given Trasylol, including 1.5 million patients in this country. Thus far, there have been about 150 cases filed nationwide against Bayer this year. A multidistrict litigation panel was set up in June 2008 in the Southern District of Florida. The first trial in the MDL has been set for January 2010.
A closer look at this drug is in order. Trasylol, the brand name for aprotinin, reduces blood loss during open-heart surgery, thereby decreasing the amount of blood needed for transfusion. In 1993, it was approved for use in high-risk cardiac surgeries and was widely used in all cardiac surgeries in subsequent years. In January 2006, a study by Dr. Dennis Mangano published in the New England Journal of Medicine concluded that the drug more than doubled the risk of renal failure. In September 2006, the FDA met with Bayer and voted to keep Trasylol on the market. However, in about one week, Bayer disclosed its own study confirming the Mangano results and the FDA issued a public health advisory. In December 2006, the drug’s label was changed to warn of potential renal dysfunction. The signature injury of this drug is kidney failure, which isn’t a common occurrence as a result of heart failure.
The FDA suspended sales of Trasylol after a Canadian BART (Blood Conservation Using Antifibrinolytics Trial) study was halted in October 2007 because patients were dying within 30 days of being given aprotinin. The final results of that study were published in May 2008, and Bayer pulled the remaining stock of Trasylol from the market. If you want more information on this drug, call Frank Woodson at 800-898-2034 or e-mail him at Frank.Woodson@beasleyallen.com.